The present invention relates to an apparatus and method for administering an atomized liquid or powdered medication substance suitable for inhalation from a nebulizer, which utilizes a portable, handheld cartridge administrator of pressurized gas, such as oxygen. Moreover, the device has the capacity to integrate supplementary modules for servo-feedback diagnostic integration. This feature helps manage the desired therapeutic outcome of the inhaled agent. These outcomes include basic lung function (spirometry), blood oxygen levels (pulse oximetry), blood glucose levels (glucometer), basal metabolic rate (BMR for VO2Max) and other simple blood or exhaled gas diagnostics.
The upper respiratory system is commonly defined as the nasopharynx (nose) oropharynx (mouth), laryngopharynx (larynx), trachea and sometimes includes the main stem bronchus and, right and left main stem bronchus. The lower respiratory tract continues through the terminal respiratory bronchioles alveolar ducts and ends with the alveolar sacs. Each progressive branch of the airways results in smaller diameters and shorter length until microscopic in size. Optimally, delivery of inhaled agents to the lower respiratory tract requires shattering a liquid or solid agent into a particle size range of between about 0.2 and 3.0 microns. Penetration of an inhaled agent is defined as the maximum depth that suspended particles can be carried into the respiratory system during a normal inspiratory effort. Deposition of the agent refers to the eventual instability of the particles resulting in a xe2x80x9cfall outxe2x80x9d on to a nearby surface. Four factors are directly related to the efficiency of deposition of optimal ranged particles: 1) kinetic activity; 2) pattern of respiratory activity; 3) gravity; and 4) inertial impaction. Kinetic Activity is defined as the erratic movement pattern of the medicinal agent irrespective of direction of flow, also known as the Brownian movement. Pattern of Respiratory Activity generally refers to the deposition and retention of inhaled particles which is directly related to inhaled volume and inversely related to ventilatory rate. Gravity refers to the influence of a suspended particle is in direct relation to the particle mass influenced by known and constant gravitational forces which follows Stokes law of Sedimentation. Finally, Inertial Impaction refers to the penetration and deposition of an inhaled agent which includes a strong influence of the theory of inertial impaction. Furthermore, this factor is based on the fact that water particles (and inhaled agents) have a greater mass than gas molecules. In addition, the force moving these particles in a straight line is greater than the force on gas molecules. When a change in direction, as in a splitting bronchiole, the probability of deposition caused by inertial impaction increases as the diameter of the conducting tube airway decreases in size. This is a significant factor in the smaller airways of the lower respiratory tract. Dose dilutions and frequency of inhaled agents has been established based on deposition of the inhaled agent(s) delivered in the optimal size range. Inhaled agents must be stable at a temperature range of 35 degrees Fahrenheit through 130 degrees Fahrenheit.
The unique nebulized features of this product is the ability to not only produce particle of optimal size for traditional inhalation to the lower respiratory tract, but also produces larger particle sizes for deposition into the upper respiratory tract. And, the unique baffling system and jet producing flows can be changed for purposeful alterations in speed of agent delivery (a factor of dilution effecting gravity, inertial impaction, and kinetic activity). Adding these features offers significant expanded utility to include non-traditional inhaled agents to effectively and efficiently be nebulized for targeted penetration and deposition that is not available within a single, mono-purpose nebulizer device. Monitoring the effectiveness of the inhaled agent and adjusting the controllable factors in a xe2x80x9cservo-controlled defined protocolxe2x80x9d adds an even greater and unique purpose and value to this system.
Many inhaled medications will have a greater safety and efficacy (dose, delivery and frequency) if a narrow window of precise medication can be delivered and cause/effect results can be directly measured, monitored and remotely adjusted. This concept is well understood with parallels seen in high blood pressure management and insulin therapy for diabetics but has not been possible for the delivery of inhaled agents. Furthermore, in some instances it is desirable to deposit agents into the upper respiratory tract, (including the nose and sinuses) transitional airways (trachea and main-stem bronchus) and lower airways for deep lung penetration. A device that included these features will open opportunities to treat traditional respiratory related diseases inflicted upon patients ranging from neonates through geriatrics. In addition, this new delivery and monitoring system provides a new foundation to inhale non-traditional drugs into the lungs such as insulin, antibiotics, pulmonary hypertension drugs, systemic hypertension drugs, hereditary enzyme deficiency replacement agents and neonatal lung-specific treatments. An additional market includes a modified, non-prescription device for naturopathic/homeopathic products. This is very promising as the general consumers in the U.S. and European markets are expanding with diet supplementation, improved vitamin absorption techniques and many new homeopathic treatment alternatives. Inhaling safe agents into the lungs is supported by clinical parameters of a highly vascularized, oxygen enriched and easily accessible delivery route for naturopathic and homeopathic supplements and treatment options.
One of two traditional markets of application includes the category of Chronic Obstructive Pulmonary Disease (COPD) which currently an estimated 16 million people in the United States are diagnosed as having. It is estimated that an additional 14 million or more are still undiagnosed, as they are in the beginning stages and have few or minimal symptoms and have not sought health care yet. COPD is an umbrella term used to describe lung disease associated with airflow obstruction. Most generally, emphysema, chronic bronchitis and chronic asthma either alone or in combinations fall into this category. There is continuing debate as to whether this term also includes Asthma (non chronic), however as a general rule, it is not included as, even though it does have obstructive components to it, it is in part reversible, and is more generally considered a restrictive lung disease.
The second traditional market is asthma. Asthma has been labeled as both a chronic lung and acute disease characterized by inflammation of the airways because of increased sensitivity to a variety of triggers, which can cause narrowing of the airways and breathing difficulty. Asthma affects 14.6 million Americans and increases by about 6% annually. Of that number, 4.8 million are children under the age of 18. Asthma is the number one cause of school absences attributed to a chronic condition. More than 5,400 people in the United States die each year from asthma. Direct and indirect costs of asthma care exceed $6 billion each year. This includes loss of time from work and school, and medical costs. To recover the cost issues, improve the outcomes of therapy and reduce the risks for loss of life, better-nebulized drug delivery and response to therapy monitoring systems will be a required tool before medical scientists and disease management protocols experts deem the disease under better control.
In general, a standard commercial asthma nebulizer is an electromechanical device that requires pressurized air to atomize liquid medication into the form of a very fine aerosol mist for patient inhalation. The pressurized air is generated from an internal portable air compressor with a maximum pressure of between about 30 and 45 psig and is driven by an electrical AC motor that generates a noise level of about 53 dBA. The pressurized air exits the electrical motor and travels through a predetermined length of polyethylene tubing to a patient hand-held medicine chamber. The patient is required to manually measure and fill the medicine chamber (6 cc/ml) with various medications in predetermined amounts as prescribed by the doctor or physician. The medicine chamber is manufactured to specific geometries that determine a nebulization rate of between about 0.15 and 0.3 ml per minute and a flow rate of between about 6 to 8 liters per minute. The medication chamber is pressurized from between about 14 and 25 psig of room air, which contains approximately 21% oxygen and is forced through the medicine chamber. The result of this event is a very fine atomized mist of less than 1 micron particle size product in 80% of the population of medication that a patient inhales. The temperature of the gas inhaled by the patient is between about 80 to 90 degrees Fahrenheit, which is created from friction being generated inside the electrical compressor.
A standard commercial nebulizer has a footprint of about 7.0xe2x80x3 widexc3x973.8xe2x80x3 highxc3x9713.0xe2x80x3 deep (18 cmxc3x9710 cmxc3x9733 cm) and weighs approximately 7 pounds to 12 pounds and requires an electrical outlet of 115VAC to operate. The treatment time with this type of device generally takes 10 minutes to 12 minutes to complete. Alternatively, ultrasonic nebulizers are an optional choice for some patients for portability and a have slightly more dispensing resolution in droplet particle size to the patient. However, to be mobile, the patient must hold these heavy units. Thus, the standard commercial asthma nebulizer is extremely large in size, burdensome and complicated to use and not generally practical to use as a portable, interim, self-sufficient device.
Thus, there is a long felt need in the field of chronic and acute respiratory care to provide a medicinal agent delivery system which is light, portable, easy to use and maintain, and is capable of servo-feedback diagnostic monitoring and real-time, physician-initiated, dosage regulation.
It is thus one aspect of the present invention to provide a technically advanced medicine nebulizing device and an associated environmental control unit for the device. The nebulizer device of the present invention is geometrically improved and considerably smaller, having the size of a miniature cellular phone, and being significantly lighter, weighing in one embodiment only about one pound, and providing more utility with virtually no mobility restrictions to the patient. The apparatus is portable enough to allow some critical care patients to leave home periodically or to travel and not require the use of an electrical outlet. The device also provides an advanced medicine delivery system attachment, which effectively allows for a hands-free operation. The medicine chamber is disposable and integrated into the patient""s state of the art headset dispenser. The headset houses a prescribed medication module and in one embodiment a music adaptor such as media player, compact disc, etc. for patient relaxation during normal treatments. The media player mechanism will also support patient training, use, and maintenance of the device, as well as communication from a treating physician by way of the Internet or phone connection.
In another aspect of the present invention, a nebulizer device is provided which is a state-of-the-art electronic medicinal environmental control unit and headset dispenser system, which utilizes a global interface between the nebulizer device, a doctor or physician, and the patient end user. The medicinal dispensing system is adaptable and can be programmed for frequent, periodic, and continual prescription adjustments to medication dosages under the doctor""s control using a cellular telephone, landline, the Internet, or by manual adjustments during office visits. Using a phone line or cellular connection will provide normal maintenance of prescription requirements, as well as provide emergency communication between the doctor, patient, and if necessary, an emergency 911 interface. In one embodiment of the present invention the patient""s condition is remotely monitored when the system is in use. More specifically, the patient""s reaction to the agent and gas flow are remotely accessed by a doctor who then compares the results of the treatment with a predetermined set of criteria or protocol. The doctor then can remotely adjust the dosage, gas flow, or both as required in order to more effectively treat the patient. Alternatively, a computer program may be used to initiate or monitor the treatment with software preprogrammed by the doctor. This automated monitoring and dosage regulation may also be accomplished with means incorporated into the system itself, wherein the protocol is initiated or adjusted during routine doctor""s office visits. The information related to patent reactions, patient condition, and dosage history, for example may be stored to facilitate the doctor""s review of patient progress.
Security features for the present invention include a unique worldwide address identification number for accessing the device prescriptions, and loss or theft identification with a global positioning system beacon to locate the device anywhere in the world and activate or deactivate the controller if required. One embodiment of the present invention includes an authentication means that verifies the patient""s and/or doctor""s fingerprints before the apparatus can be initiated. When using the Internet, the environmental control unit can be programmed and analyzed by downloading statistical data back to the doctor providing patient progress. In one embodiment, the environmental control unit can receive system updates and repairs that are performed on-line from a personal computer by means of an input/output device, such as a RS-232 port. Further, the electronic control device may offer a liquid crystal display with a soft glow backlight showing features such as a multi-segment battery status, mode of dispensing indicator, temperature display in Fahrenheit/Centigrade, vibration treatment timer with stealth vibrator indicator, dosage cycle counter, electronic safety and sleep indicator, treatment locked menu selection with real status indicators, processing power for multiple modes of dispensing, preset pulsating and automatic run dispensing features. This controlled supervision and independence allows the patient and doctor to determine and/or prescribe the rate, frequency, and timing of aerosol prescriptions while the patient enjoys the opportunity to live a more normal life.
In another aspect of the present invention, an operating system is provided with the present nebulizer device, which includes device firmware code and a software program for managing the doctor""s prescription for treatment. The communication of the doctor""s prescription to the patient is accomplished by a software program arrangement using a personal computer port connection in conjunction with a phone call from a landline or a cell phone signal. The medicine-nebulizing device is powered in one embodiment with a standardized battery operation providing virtually a muted operation so the patient realizes a relaxed environment for treatment. This device is more efficient, effective and comfortable than conventional nebulizer systems for asthma patients. In another embodiment of the present invention the nebulizer operates under free physical pressure. More specifically, the nebulizer is equipped with a venturi or inductor device which increases the velocity of the incoming gas thereby creating a localized low pressure area which facilitates agent mixture and inhalation.
It is a further aspect of the present invention to utilize a portable refillable compressed gas, such as highly concentrated oxygen (O2), as opposed to an electrical motor to generate compressed gas. The use of portable compressed gas such as oxygen serves two purposes. The first is to introduce a cooler, higher density gas into the patient""s lungs, which may allow the breathing passages to realize a deeper penetration and absorption of the required medication for treatment. The deeper penetration into the lungs may allow for a quicker physiological response resulting in a faster event recovery as well as less medication requirements suggesting the treatment to be a more efficient process than conventional methods. In one embodiment of the present invention the compressed gas is 95% oxygen with the remaining 5% of gas consisting of Nitrogen (N2), Argon (Ar) or other compatible gas similar to the requirements of an oxygen concentrator. This process may also reduce the duration time and the amount of medication required for each treatment, thus making it a very efficient and effective system. Although, compressed oxygen is the preferred method of gas delivery to the patient, one skilled in the art will appreciate that many other compressed gases such as purified air, Nitrogen (N2), and Argon (Ar) may be employed. Secondly, the compressed gas would provide sufficient energy to pressurize the entire nebulizer system and dispense the required medication to the patient between about 35 and 70 degrees Fahrenheit and which further acts as a cooling mechanism for a pump motor and/or control valve as it passes through each controlling component in the device. Thus, in one embodiment of the present invention, a disposable gas cartridge administrator is provided to support and contain a pressurized gas cartridge and to regulate the flow of compressed gas to the internal passages of the pressure regulator.
It is thus a further aspect of the present invention to provide an improved gas regulator with reduced size and convenient geometric configuration for portable and convenience use. This requirement is needed to accommodate special constraints in many other medical apparatus. It is another aspect of the present invention to provide an improved gas regulator, which provides a high degree of resistance to sustained pressure within the regulator body. It is also a particular aspect of the present invention to provide an improved gas regulator, which includes a flow control mechanism for selectively controlling the pressure and rate of gas, as well as purity of the gas, which travels through the regulator body.
It is another aspect of the present invention to provide a medicine chamber that is capable of receiving one or a plurality of medicinal agents. Depending on the patient""s condition, treatment with different agents at different times may be required. The medicine chamber may be equipped with the means to dispense the desired medication from a plurality of medications without mixing the agents. In another embodiment of the present invention the agent is compressed into thin strips or wafers that are inserted into a plurality of slots in the medicine chamber. Alternatively, a patient may need a plurality of agents administered concurrently which is achievable by the same dispensing means.
As may be appreciated by one skilled in the art, it is another aspect of the present invention that this device may also be utilized in other areas of alternative medicinal treatments such as homeopathic, herbal, mineral, and vitamin health, wherein different types of medicines and drugs can be quickly and effectively administered to a patient in the form of a cooled gas, such as high oxygen concentration gas.
Thus it is one aspect of the present invention to provide a method for monitoring and administering an atomized liquid medication from a portable, compressed gas cartridge, that comprises the steps of:
providing a cartridge administer adapted for receiving a portable cartridge of a high pressure gas;
reducing the pressure of the high pressure gas to a reduced pressure gas having a pressure no greater than about 50 psig;
generating a plurality of aerosol sized particles from said reduced pressure gas which have a diameter no greater than about 3 microns;
introducing a predetermined dose of a prescribed medicine into a stream of said aerosol sized particles to create a prescribed medicinal gas; and
dispensing said prescribed medicinal gas to a patient at a predetermined rate of flow through an oral dispensing apparatus.